Shanghai-based Micurx Pharmaceuticals Inc. is preparing to file an NDA for its lead antibacterial candidate, contezolid, with China's National Medical Products Administration after results of a pivotal phase III trial there showed the drug providing comparable clinical cure rates to linezolid for complicated skin and soft tissue infections (cSSTI). Reduced hematologic toxicity for the tablet-based antibiotic vs. linezolid was also seen, highlighting one of contezolid's key advantages.
With an eye to preparing for potential threats, the FDA has granted approval for the first live, non-replicating vaccine to prevent smallpox and monkeypox. Developed by Bavarian Nordic A/S and branded as Jynneos, after a priority review it was approved for prevention of the diseases in adults determined to be at high risk for the viral infections.
Shares of Abeona Therapeutics Inc. (NASDAQ:ABEO) fell 12% Monday to $2.87 after the FDA put a clinical hold on a phase III study of its autologous cell therapy for recessive dystrophic epidermolysis bullosa (RDEB), a trial that had initially been slated to start by mid-2019.
Seeking to address a rising tide of retinal disease, Boehringer Ingelheim GmbH has agreed to pay Newton, Mass.-based Inflammasome Therapeutics Inc. as much as $160 million for rights to use its intravitreal drug delivery technology with up to three Boehringer compounds.
Shanghai-based Micurx Pharmaceuticals Inc. is preparing to file an NDA for its lead antibacterial candidate, contezolid, with China's National Medical Products Administration after results of a pivotal phase III trial there showed the drug providing comparable clinical cure rates to linezolid for complicated skin and soft tissue infections (cSSTI). Reduced hematologic toxicity for the tablet-based antibiotic vs. linezolid was also seen, highlighting one of contezolid's key advantages.
Metacrine Inc., a San Diego company developing new therapies for liver and gastrointestinal diseases, has inked a loan and security agreement worth up to $50 million with the private equity-backed health care financier K2 Healthventures (K2HV). Metacrine has raised almost $125 million since its founding. New nondilutive funding will support a robust clinical development plan in 2020, CEO Ken Song told BioWorld.
Shares of San Diego-based Tocagen Inc. (NASDAQ:TOCA) fell 77.7% to 93 cents on Sept. 12, and further since, after its two-part immunotherapy for people with recurrent brain cancer failed to surpass standard of care on overall survival (OS), the primary endpoint of the company's phase III Toca 5 trial. Secondary endpoints in the registrational study were also missed, showing no meaningful difference between study arms.
Shares of Aclaris Therapeutics Inc. (NASDAQ:ACRS) rose 64% to $1.80 Tuesday on news that A-101, its topical treatment of verruca vulgaris, or common warts, met both the primary and all secondary efficacy endpoints of the phase III THWART-2 trial, the first of two pivotal studies intended to support an NDA filing for the drug, a high-concentration topical hydrogen peroxide solution. The other trial, THWART-1, is expected to read out in the fourth quarter.
Following data from a small phase IIa study showing its experimental Alzheimer's disease (AD) therapy, PTI-125, led to decreases in key biomarkers of neuroinflammation and neurodegeneration, Cassava Sciences Inc. (formerly Pain Therapeutics) has dosed the first two patients in a phase IIb study of the candidate.
